ProGuide Needles

GUDID 08717213025011

ProGuide Obturator 5Fx240 mm

Nucletron B.V.

General-purpose brachytherapy system applicator, remote-afterloading

• Primary Device ID: 08717213025011
• NIH Device Record Key: 59bac7b7-4161-4086-ab8a-a507594a2b0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProGuide Needles
• Version Model Number: 189655-01
• Company DUNS: 415269930
• Company Name: Nucletron B.V.
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(770)300-9725
• Email: info.america@elekta.com

Device Dimensions

• Length: 240 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717213025011 [Direct Marking]
GS1	08717213052925 [Primary]
GS1	08717213054738 [Package]; Contains: 08717213052925; Package: [2 Units]; In Commercial Distribution
GS1	88717213025017 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060349

FDA Product Code

• JAQ: System, applicator, radionuclide, remote-controlled

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08717213025011]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-13
• Device Publish Date: 2020-02-05

On-Brand Devices [ProGuide Needles]

• 08717213054486: ProGuide Round Needle 6Fx294mm
• 08717213054493: ProGuide Sharp Needle 6Fx294mm
• 08717213054707: ProGuide Round Needle 6Fx200mm
• 08717213054691: ProGuide Round Needle 6Fx240mm
• 08717213054684: ProGuide Sharp Needle 5Fx240mm
• 08717213054677: ProGuide Sharp Needle 6Fx200mm
• 08717213054660: ProGuide Sharp Needle 6Fx240mm
• 08717213054653: ProGuide Round Needle Set 6Fx200mm
• 08717213054646: ProGuide Round Needle Set 6Fx240mm
• 08717213054639: ProGuide Sharp Needle Set 5Fx240mm
• 08717213054622: ProGuide Sharp Needle Set 6Fx200mm
• 08717213054479: ProGuide Sharp Needle Set 6Fx240mm
• 08717213054615: ProGuide Sharp Needle 5Fx240mm
• 08717213054578: ProGuide Sharp Needle 6Fx200mm
• 08717213054530: ProGuide Sharp Needle 6Fx240mm
• 08717213054592: ProGuide Sharp Needle 5Fx240mm
• 08717213054554: ProGuide Sharp Needle 6Fx200mm
• 08717213054523: ProGuide Sharp Needle 6Fx240mm
• 08717213053847: ProGuide Round Needle 6Fx200mm
• 08717213053809: ProGuide Round Needle 6Fx240mm
• 08717213053793: ProGuide Round Needle 6Fx200mm
• 08717213052932: ProGuide Round Needle 6Fx240mm
• 08717213025073: ProGuide Obturator 6Fx200 mm
• 08717213025110: ProGuide Obturator 6Fx240 mm
• 08717213025011: ProGuide Obturator 5Fx240 mm